Prospective Trial for the Diagnosis and Treatment of Intracranial Germ Cell Tumors (SIOPCNSGCTII)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2013 by University Hospital Muenster
Sponsor:
University Hospital Muenster
Collaborators:
Deutsche Kinderkrebsstiftung
Hannover Medical School
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01424839
First received: August 11, 2011
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
STUDY DESIGN:
Prospective, non-randomised multicentre study with patients stratified according to risk groups INVESTIGATIONAL MEDICINAL PRODUCTS The IMPs on this trial are Carboplatin, Cisplatin, Ifosfamide and Etoposide (as approved by German competent authority).
PRIMARY OBJECTIVES:
Germinoma
- To maintain current high event-free survival (EFS) rates using a risk adapted approach
- In localised germinoma: to omit whole brain and spinal irradiation by using combined treatment with standard chemotherapy and ventricular irradiation (+/- boosts)
- In bifocal tumours (pineal + suprasellar): to treat as non-metastatic disease and to omit whole brain and spinal irradiation by using combined treatment with standard chemotherapy and ventricular irradiation (+/- boosts)
- In metastatic disease: to maintain current excellent EFS in metastatic germinoma with craniospinal irradiation Malignant non-germinoma
To improve EFS:
- by dose escalation of chemotherapy in patients identified as high risk at diagnosis ( age < 6 years and/or AFP serum / CSF > 1000 ng/ml)
- by standardising the surgical approach for residual disease after treatment Teratoma
- To register patients and collect data regarding diagnostics, treatment and outcome in order to develop future treatment strategies
SECONDARY OBJECTIVES:
Germinoma
- To minimise long term effects of irradiation by sparing spinal and whole brain radiotherapy in non-metastatic disease Malignant non-germinoma
- In standard risk to maintain EFS with chemotherapy and local irradiation Teratoma
- To evaluate the influence of surgery and treatment on outcome to assist in the development of a fu-ture treatment strategy For all histological subtypes
- To improve accuracy of diagnosis and staging in all registered patients
- To standardise neurosurgical intervention
- For all patients requiring biopsy or resection according to protocol guidelines, to collect and to store tumour material, and CSF where possible, for use in future biological studies.
ENDPOINTS / Criteria for evaluation:
Main end point
Event-free survival, defined as minimum time from the date of diagnosis to:
- Death from any cause
- Relapse
- Progressive disease on therapy
- Or second malignancy
Secondary end points
- Overall survival, defined as time to death from any cause, measured from the date of diagnosis
- Short and long term toxicity.
| Condition | Intervention | Phase |
|---|---|---|
|
Intracranial Germ Cell Tumors |
Radiation: craniospinal irradiation Drug: Carboplatin, Etoposide, Ifosfamide Radiation: ventricular irradiation Drug: Cisplatin, etoposide, Ifosfamide (standard) Drug: Cisplatin, Etoposide, Ifosfamide (high dose) Radiation: focal irradiation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | SIOP CNS GCT II: Prospective Trial for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Intracranial Germ Cell Tumors |
Resource links provided by NLM:
Further study details as provided by University Hospital Muenster:
Primary Outcome Measures:
- survival [ Time Frame: 5 years event free survival ] [ Designated as safety issue: Yes ]Survival rates in respect to applied treatment , according to Kaplan-Meier estimation , 5 years event free survival
Secondary Outcome Measures:
- short and long term toxicity [ Time Frame: until 7 years after start of trial ] [ Designated as safety issue: Yes ]toxicity of treatment will be assessed with CTC criteria, severe toxicity will be analysed by safety desk
- overall survival [ Time Frame: 7 years after start of trial ] [ Designated as safety issue: Yes ]Overall survival will be measured by Kaplan -Meier Estimation , 5 years overall survival
| Estimated Enrollment: | 400 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2018 |
| Estimated Primary Completion Date: | October 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Germinoma metastatic
• Metastatic or incompletely staged germinomas (± teratoma) Do not receive chemotherapy in this protocol Radiotherapy
|
Radiation: craniospinal irradiation
|
|
germinoma non-metastatic
Chemotherapy: • Non-metastatic fully staged germinoma (± teratoma) Two courses (1 and 3) of Etoposide and Carboplatin, alternating with two courses (2 and 4) of Etoposide and Ifosfamide Note: Bifocal germinoma (pineal+suprasellar) are treated as non-metastatic germinoma, if staging shows no additional dissemination Radiotherapy
|
Drug: Carboplatin, Etoposide, Ifosfamide
• Non-metastatic fully staged germinoma (± teratoma) Two courses (1 and 3) of Etoposide and Carboplatin, alternating with two courses (2 and 4) of Etoposide and Ifosfamide
Radiation: ventricular irradiation
|
|
Non-germinoma non-metastatic standard risk
Chemotherapy: • Standard risk non-germinomatous malignant GCT Four courses of Etoposide, Cisplatin and Ifosfamide (standard treatment ) After Chemotherapy: 54 Gy focal radiotherapy in 30 fractions |
Drug: Cisplatin, etoposide, Ifosfamide (standard)
Four courses of Etoposide, Cisplatin and Ifosfamide (standard treatment )
Radiation: focal irradiation
• Patients with localised non-germinomatous disease at diagnosis After Chemotherapy: 54 Gy focal radiotherapy in 30 fractions
|
|
Non-Germinoma metastatic standard risk
Chemotherapy Four courses of Etoposide, Cisplatin and Ifosfamide (standard treatment ) Radiotherapy After Chemotherapy: 30 Gy (20 fractions) to craniospinal axis with 24 Gy (15 fraction) boosts to tumour site and any intracranial metastases (total tumour dose 54 Gy) and 20.8 Gy (13 fraction) boosts to spinal deposits (total dose 50.8 Gy)
|
Radiation: craniospinal irradiation
Four courses of Etoposide, Cisplatin and Ifosfamide (standard treatment )
|
|
Non-germinoma non-metastatic high risk
Chemotherapy Two courses of standard Etoposide, Cisplatin and Ifosfamide, followed by two dose intensified courses of Etoposide, Cisplatin and Ifosfamide with stem cell support Radiotherapy After Chemotherapy: 54 Gy focal radiotherapy in 30 fractions
|
Drug: Cisplatin, Etoposide, Ifosfamide (high dose)
Two courses of standard Etoposide, Cisplatin and Ifosfamide, followed by two dose intensified courses of Etoposide, Cisplatin and Ifosfamide with stem cell support
Radiation: focal irradiation
• Patients with localised non-germinomatous disease at diagnosis After Chemotherapy: 54 Gy focal radiotherapy in 30 fractions
|
|
Non-Germinoma metastatic high risk
Chemotherapy Two courses of standard Etoposide, Cisplatin and Ifosfamide, followed by two dose intensified courses of Etoposide, Cisplatin and Ifosfamide with stem cell support Radiotherapy After Chemotherapy: 30 Gy (20 fractions) to craniospinal axis with 24 Gy (15 fraction) boosts to tumour site and any intracranial metastases (total tumour dose 54 Gy) and 20.8 Gy (13 fraction) boosts to spinal deposits (total dose 50.8 Gy)
|
Radiation: craniospinal irradiation
Two courses of standard Etoposide, Cisplatin and Ifosfamide, followed by two dose intensified courses of Etoposide, Cisplatin and Ifosfamide with stem cell support
|
|
No Intervention: Teratoma
collection of information on surgery, applied treatment and outcome
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Main residence in one of the participating countries
- Primary diagnosis of an intracranial germ cell tumour
- Written consent for trial participation, treatment according to the protocol and consent for data transfer
Exclusion Criteria:
- Tumour entity other than primary intracranial germ cell tumour or CNS GCT as second malignancy
- Primary diagnosis pre-dating the opening of SIOP CNS GCT II in the participating country of registration
- Medical, psychiatric or social conditions incompatible with trial treatment or treatment according to protocol is not intended
- Participation within a different trial for treatment of germ cell tumours and/or concurrent treatment within any other clinical trial. The only exceptions to this are trials with different endpoints, involving aspects of supportive treatment which can run parallel to SIOP CNS GCT II without influencing the outcome of this trial e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support etc.
- Pregnancy and lactation
- Any treatment not given according to protocol prior to registration
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424839
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424839
Contacts
| Contact: Gabriele Calaminus, MD | +492518358060 | gabriele.calaminus@ukmuenster.de | |
| Contact: Carmen Teske | +492518358055 | carmen.teske@ukmuenster.de |
Locations
| Germany | |
| University Hospital Muenster | Recruiting |
| Muenster, Germany, 48129 | |
| Contact: Gabriele Calaminus, MD +492518358060 gabriele.calaminus@ukmuenster.de | |
| Contact: Carmen Teske +492518358055 carmen.teske@ukmuenster.de | |
| Principal Investigator: Gabriele Calaminus, MD | |
Sponsors and Collaborators
University Hospital Muenster
Deutsche Kinderkrebsstiftung
Hannover Medical School
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Investigators
| Principal Investigator: | Gabriele Calaminus, MD | University Hospital Muenster |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital Muenster |
| ClinicalTrials.gov Identifier: | NCT01424839 History of Changes |
| Other Study ID Numbers: | UKM08_0057, 2009-018072-33 |
| Study First Received: | August 11, 2011 |
| Last Updated: | January 22, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital Muenster:
|
SIOP CNS GCT II Patients with the primary disease of an Intracranial Germ Cell Tumors |
Additional relevant MeSH terms:
|
Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Carboplatin Cisplatin Etoposide Etoposide phosphate Ifosfamide Isophosphamide mustard Alkylating Agents |
Antineoplastic Agents Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on February 25, 2015